In Step Toward Approval, FDA Confirms Efficacy And Safety Of Pfizer’s Vaccine
The Food and Drug Administration's independent review of clinical trial data for Pfizer and BioNTech's vaccine upholds findings about its protection against COVID-19 as well as safety, according to briefing documents written up for Thursday's advisory panel meeting.
The New York Times:
Pfizer’s Vaccine Offers Strong Protection After First Dose
The coronavirus vaccine made by Pfizer and BioNTech provides strong protection against Covid-19 within about 10 days of the first dose, according to documents published on Tuesday by the Food and Drug Administration before a meeting of its vaccine advisory group.The finding is one of several significant new results featured in the briefing materials, which include more than 100 pages of data analyses from the agency and from Pfizer. Last month, Pfizer and BioNTech announced that their two-dose vaccine had an efficacy rate of 95 percent after two doses administered three weeks apart. The new analyses show that the protection starts kicking in far earlier. (Weiland and Zimmer, 12/8)
CNBC:
FDA Says Pfizer Covid Vaccine Provides Some Protection After First Dose, Meets Success Criteria
In briefing documents published ahead of an advisory meeting Thursday to review Pfizer’s vaccine, FDA staff also said data submitted appeared to show the vaccine provided protection after the first dose. Pfizer’s vaccine requires two doses about three weeks apart. Two doses of the vaccine were “highly effective” in preventing confirmed cases of Covid-19 at least seven days following the second dose, the agency said. “As such, FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the agency wrote in documents posted on its website. (Lovelace Jr., 12/8)
The Wall Street Journal:
FDA Says Pfizer/BioNTech Vaccine Meets Success Criteria
In addition, the FDA said another benefit was reduction in the risk of confirmed Covid-19 after the first dose and before the second dose. Another clear benefit, the agency said, was “reduction in the risk of confirmed severe Covid-19 any time after dose 1.” The reference to reduction in confirmed severe disease was important, as early critics of some of the vaccine trials were concerned that only mild to moderate disease was prevented. (Burton and Hopkins, 12/8)
The Washington Post:
FDA Review Confirms Safety And Efficacy Of Pfizer Coronavirus Vaccine
On Thursday, a group of advisers to the FDA will meet for a full-day public meeting to discuss the data and make recommendations on whether the vaccine merits authorization for immediate use. A decision, informed but not dictated by that debate, is expected to come within days of the meeting. The first doses are expected to be shipped within hours, with a target of 6.4 million doses distributed in the first week. (Johnson, McGinley, Alcantara and Steckelberg, 12/8)
